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As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more
The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more
The Spanish Data Protection Authority published on Friday on its website the new "Code of Conduct on the processing of personal data in the field of clinical trials and other clinical research as well as pharmacovigilance"...more
ANTITRUST AND COMPETITION - The European Commission Opens a New Investigation in the Pharma Sector - On 4 March 2021, the European Commission (Commission) has opened a formal investigation into alleged misuses of patent...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
Clinical trials in the EU include the collection of sensitive health data from patients. Trial sponsors are obliged to reconcile their respect of regulations governing data protection with regulations governing the conduct of...more
On January 23, 2019, the European Data Protection Board (“EDPB”) issued an interesting opinion about personal data processed in relation to clinical trials. The main role of the EDPB – which succeeded the Article 29...more
On January 23, 2019, the European Data Protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, adopted an Advisory Opinion...more
With the coming into effect of the General Data Protection Regulation (GDPR), those conducting clinical trials in the EU face a complex set of rules ranging from lawful grounds for processing and transparency to restrictions...more
The European Data protection Board (“EDPB”), which is composed of representatives of the national data protection authorities and the European Data Protection Supervisor, recently adopted an Advisory Opinion (“Opinion”) on...more
With the recent ruling that the Safe Harbor programme is invalid under European law, life sciences companies will need to review their strategies when exporting patient data to the United States....more